Actuation mechanisms and load adjustment assemblies for surgical instruments

ABSTRACT

An ultrasonic surgical instrument includes an inner tube, an outer tube, an ultrasonic blade, and a clamp member pivotably moveable relative to the ultrasonic blade. The ultrasonic blade is acoustically coupled to an ultrasonic transducer. The clamp member pivotably movable relative to the ultrasonic blade between an open configuration and an approximated configuration with respect to the ultrasonic blade, wherein the clamp member is pivotably coupled to the inner tube, wherein the clamp member is pivotably coupled to the outer tube, and wherein movement of the outer tube relative to the inner tube between the first position and the second position transitions the clamp member between the open configuration and the approximate configuration.

BACKGROUND

The present disclosure is related generally to surgical instrumentsincluding ultrasonic instruments. Ultrasonic surgical instruments, suchas ultrasonic scalpels, are used in many applications in surgicalprocedures by virtue of their unique performance characteristics.Ultrasonic surgical instruments can be configured for open surgical use,laparoscopic, or endoscopic surgical procedures includingrobotic-assisted procedures.

DRAWINGS

The features of the various embodiments are set forth with particularityin the appended claims. The various embodiments, however, both as toorganization and methods of operation, together with advantages thereof,may best be understood by reference to the following description, takenin conjunction with the accompanying drawings as follows:

FIG. 1 illustrates a surgical system including a surgical instrument andan ultrasonic generator;

FIG. 2 illustrates the surgical instrument shown in FIG. 1;

FIG. 2A illustrates a distal portion of the surgical instrument of FIG.2 including an ultrasonic end effector;

FIG. 3 illustrates a distal portion of the surgical instrument of FIG. 2including an ultrasonic end effector;

FIG. 4 illustrates an exploded view of the distal portion of FIG. 3;

FIG. 5 illustrates a clamp member of the surgical instrument of FIG. 2;

FIG. 6 illustrates a longitudinal cross-sectional view of the distalportion of FIG. 2A;

FIG. 6A illustrates a partial longitudinal cross-sectional view of anelongated shaft assembly of the surgical instrument of FIG. 2;

FIG. 7 illustrates a partial perspective view of an inner tube and analignment feature of the surgical instrument of FIG. 2;

FIG. 8 illustrates a partial perspective view of an ultrasonic blade ofthe surgical instrument of FIG. 2;

FIG. 9 illustrates a partial longitudinal cross-sectional view of theultrasonic blade of FIG. 7;

FIG. 10 illustrates a transverse cross-sectional view of an elongatedshaft assembly of the surgical instrument of FIG. 2;

FIG. 11 illustrates a cross-sectional view of a distal portion of thesurgical instrument of FIG. 2 with a removed outer tube;

FIG. 12 illustrates a perspective cross-sectional view of a retainingcap of the distal portion of FIG. 11;

FIG. 13 illustrates a transverse cross-sectional view of an ultrasonicblade, an inner tube, and an insert of the surgical instrument of FIG.2;

FIG. 14 illustrates a transverse cross-sectional view of an ultrasonicblade and a channel of the surgical instrument of FIG. 2;

FIG. 15 illustrates a partial longitudinal cross-sectional view of theultrasonic blade and the channel of FIG. 14;

FIG. 16 illustrates a side elevational view of a surgical instrument;

FIG. 17 illustrates a transverse cross-sectional view of the surgicalinstrument of FIG. 16;

FIG. 18 illustrates a perspective view of a blade of the surgicalinstrument of FIG. 16;

FIG. 19 illustrates a partial longitudinal cross-sectional view of asupport shaft of the surgical instrument of FIG. 16;

FIG. 20 illustrates a partial perspective view of the support shaft ofFIG. 19;

FIG. 21 illustrates a partial perspective view of the surgicalinstrument of FIG. 2 with several parts removed from the handle assemblyto expose a load adjustment assembly and a reciprocating actuationmember of the handle assembly of the surgical instrument of FIG. 2;

FIG. 21A illustrates the load adjustment assembly of FIG. 21 with thereciprocating actuation member at an unactuated position;

FIG. 21B illustrates the load adjustment assembly of FIG. 21 with thereciprocating actuation member at an actuated position;

FIG. 22 illustrates a partial exploded view of the surgical instrumentof FIG. 2;

FIG. 23 illustrates a partial longitudinal cross-sectional view of acollar, and a load adjustment member of the load adjustment assembly ofFIG. 21;

FIG. 24 illustrates a perspective view of a load adjustment assembly ofthe surgical instrument of FIG. 2;

FIG. 25 illustrates is an exploded view of a collar, a drive shaft, anda load adjustment member of the load adjustment assembly of FIG. 24;

FIG. 26 illustrates a side-elevational view of a load adjustmentassembly of the surgical instrument of FIG. 2 with an unattached loadadjustment member;

FIG. 26A illustrates a side-elevational view of the load adjustmentassembly of the surgical instrument of FIG. 2 with an attached loadadjustment member;

FIG. 27 illustrates a perspective of a handle assembly of the surgicalinstrument of FIG. 2, wherein a left shell of the handle assembly isremoved to expose a load adjustment assembly;

FIG. 28 illustrates an exploded view of a load adjustment assembly ofthe handle assembly of FIG. 27; and

FIG. 29 illustrates a side-elevational view of a load adjustmentassembly of the surgical instrument of FIG. 2.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate various embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DESCRIPTION

Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. It will be understood by those skilled in theart, however, that the embodiments may be practiced without suchspecific details. In other instances, well-known operations, components,and elements have not been described in detail so as not to obscure theembodiments described in the specification. Those of ordinary skill inthe art will understand that the embodiments described and illustratedherein are non-limiting examples, and thus it can be appreciated thatthe specific structural and functional details disclosed herein may berepresentative and illustrative. Variations and changes thereto may bemade without departing from the scope of the claims.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Furthermore, it will be appreciated that for conciseness andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down”, for example, may be used herein with respect to the illustratedembodiments. However, these terms are used to assist the reader and arenot intended to be limiting and absolute.

Turning now to the figures, FIG. 1 illustrates a right side view of oneembodiment of an ultrasonic surgical instrument 10. In the illustratedembodiment, the ultrasonic surgical instrument 10 may be employed invarious surgical procedures including endoscopic or traditional opensurgical procedures. In one example embodiment, the ultrasonic surgicalinstrument 10 comprises a handle assembly 12, an elongated shaftassembly 14, an ultrasonic transducer 16, and a blade 66. The handleassembly 12 comprises a trigger assembly 24, a distal rotation assembly13, and a switch assembly 28. The elongated shaft assembly 14 comprisesan end effector assembly 26, which comprises elements to dissect tissueor mutually grasp, cut, and coagulate vessels and/or tissue, andactuating elements to actuate the end effector assembly 26. The handleassembly 12 is adapted to receive the ultrasonic transducer 16 at theproximal end. The ultrasonic transducer 16 can be mechanically engagedto the elongated shaft assembly 14 and portions of the end effectorassembly 26. The ultrasonic transducer 16 can be electrically coupled toa generator 20 via a cable 22. In certain instances, the generator canbe integrated with the handle assembly 12, for example. Although themajority of the drawings depict a multiple end effector assembly 26 foruse in connection with laparoscopic surgical procedures, the ultrasonicsurgical instrument 10 may be employed in more traditional open surgicalprocedures and in other embodiments, may be configured for use inendoscopic procedures. For the purposes herein, the ultrasonic surgicalinstrument 10 is described in terms of an endoscopic instrument;however, it is contemplated that an open and/or laparoscopic version ofthe ultrasonic surgical instrument 10 also may include the same orsimilar operating components and features as described herein.

In various embodiments, the generator 20 comprises several functionalelements, such as modules and/or blocks. Different functional elementsor modules may be configured for driving different kinds of surgicaldevices. For example, an ultrasonic generator module 21 may drive anultrasonic device, such as the ultrasonic surgical instrument 10. Insome example embodiments, the generator 20 also comprises anelectrosurgery/RF generator module 23 for driving an electrosurgicaldevice (or an electrosurgical embodiment of the ultrasonic surgicalinstrument 10). In the example embodiment illustrated in FIG. 1, thegenerator 20 includes a control system 25 integral with the generator20, and a foot switch 29 connected to the generator via a cable 27. Thegenerator 20 may also comprise a triggering mechanism for activating asurgical instrument, such as the instrument 10. The triggering mechanismmay include a power switch (not shown) as well as a foot switch 29. Whenactivated by the foot switch 29, the generator 20 may provide energy todrive the acoustic assembly of the surgical instrument 10 and to drivethe end effector 18 at a predetermined excursion level. The generator 20drives or excites the acoustic assembly at any suitable resonantfrequency of the acoustic assembly and/or derives thetherapeutic/sub-therapeutic electromagnetic/RF energy.

In one embodiment, the electrosurgical/RF generator module 23 may beimplemented as an electrosurgery unit (ESU) capable of supplying powersufficient to perform bipolar electrosurgery using radio frequency (RF)energy. In one embodiment, the ESU can be a bipolar ERBE ICC 350 sold byERBE USA, Inc. of Marietta, Ga. In bipolar electrosurgery applications,as previously discussed, a surgical instrument having an activeelectrode and a return electrode can be utilized, wherein the activeelectrode and the return electrode can be positioned against, oradjacent to, the tissue to be treated such that current can flow fromthe active electrode to the return electrode through the tissue.Accordingly, the electrosurgical/RF module 23 generator may beconfigured for therapeutic purposes by applying electrical energy to thetissue T sufficient for treating the tissue (e.g., cauterization).

In one embodiment, the electrosurgical/RF generator module 23 may beconfigured to deliver a subtherapeutic RF signal to implement a tissueimpedance measurement module. In one embodiment, the electrosurgical/RFgenerator module 23 comprises a bipolar radio frequency generator asdescribed in more detail below. In one embodiment, theelectrosurgical/RF generator module 12 may be configured to monitorelectrical impedance Z, of tissue T and to control the characteristicsof time and power level based on the tissue T by way of a returnelectrode provided on a clamp member of the end effector assembly 26.Accordingly, the electrosurgical/RF generator module 23 may beconfigured for subtherapeutic purposes for measuring the impedance orother electrical characteristics of the tissue T. Techniques and circuitconfigurations for measuring the impedance or other electricalcharacteristics of tissue T are discussed in more detail in commonlyassigned U.S. Patent Publication No. 2011/0015631, titled“Electrosurgical Generator for Ultrasonic Surgical Instrument,” thedisclosure of which is herein incorporated by reference in its entirety.

A suitable ultrasonic generator module 21 may be configured tofunctionally operate in a manner similar to the GEN300 sold by EthiconEndo-Surgery, Inc. of Cincinnati, Ohio as is disclosed in one or more ofthe following U.S. patents, all of which are incorporated by referenceherein in their entireties: U.S. Pat. No. 6,480,796 (METHOD FORIMPROVING THE START UP OF AN ULTRASONIC SYSTEM UNDER ZERO LOADCONDITIONS); U.S. Pat. No. 6,537,291 (METHOD FOR DETECTING BLADEBREAKAGE USING RATE AND/OR IMPEDANCE INFORMATION); U.S. Pat. No.6,662,127 (METHOD FOR DETECTING PRESENCE OF A BLADE IN AN ULTRASONICSYSTEM); U.S. Pat. No. 6,977,495 (DETECTION CIRCUITRY FOR SURGICALHANDPIECE SYSTEM); U.S. Pat. No. 7,077,853 (METHOD FOR CALCULATINGTRANSDUCER CAPACITANCE TO DETERMINE TRANSDUCER TEMPERATURE); U.S. Pat.No. 7,179,271 (METHOD FOR DRIVING AN ULTRASONIC SYSTEM TO IMPROVEACQUISITION OF BLADE RESONANCE FREQUENCY AT STARTUP); and U.S. Pat. No.7,273,483 (APPARATUS AND METHOD FOR ALERTING GENERATOR FUNCTION IN ANULTRASONIC SURGICAL SYSTEM). Furthermore, U.S. Patent ApplicationPublication No. 2014/0005702 A1, entitled ULTRASONIC SURGICALINSTRUMENTS WITH DISTALLY POSITIONED TRANSDUCERS, and filed on Jun. 29,2012, is incorporated by reference herein in its entirety.

It will be appreciated that in various embodiments, the generator 20 maybe configured to operate in several modes. In one mode, the generator 20may be configured such that the ultrasonic generator module 21 and theelectrosurgical/RF generator module 23 may be operated independently.

For example, the ultrasonic generator module 21 may be activated toapply ultrasonic energy to the end effector assembly 26 andsubsequently, either therapeutic sub-therapeutic RF energy may beapplied to the end effector assembly 26 by the electrosurgical/RFgenerator module 23. As previously discussed, the sub-therapeuticelectrosurgical/RF energy may be applied to tissue clamped between claimelements of the end effector assembly 26 to measure tissue impedance tocontrol the activation, or modify the activation, of the ultrasonicgenerator module 21. Tissue impedance feedback from the application ofthe sub-therapeutic energy also may be employed to activate atherapeutic level of the electrosurgical/RF generator module 23 to sealthe tissue (e.g., vessel) clamped between claim elements of the endeffector assembly 26.

In another embodiment, the ultrasonic generator module 21 and theelectrosurgical/RF generator module 23 may be activated simultaneously.In one example, the ultrasonic generator module 21 is simultaneouslyactivated with a sub-therapeutic RF energy level to measure tissueimpedance simultaneously while an ultrasonic blade such as, for example,the blade 66 of the end effector assembly 26 cuts and coagulates thetissue (or vessel) clamped between the clamp elements of the endeffector assembly 26. Such feedback may be employed, for example, tomodify the drive output of the ultrasonic generator module 21. Inanother example, the ultrasonic generator module 21 may be drivensimultaneously with electrosurgical/RF generator module 23 such that theultrasonic blade 66 of the end effector assembly 26 is employed forcutting the damaged tissue while the electrosurgical/RF energy isapplied to electrode portions of the end effector clamp assembly 26 forsealing the tissue (or vessel).

When the generator 20 is activated via the triggering mechanism,electrical energy is continuously applied by the generator 20 to atransducer stack or assembly of the acoustic assembly. In anotherembodiment, electrical energy is intermittently applied (e.g., pulsed)by the generator 20. A phase-locked loop in the control system of thegenerator 20 may monitor feedback from the acoustic assembly. The phaselock loop adjusts the frequency of the electrical energy sent by thegenerator 20 to match the resonant frequency of the selectedlongitudinal mode of vibration of the acoustic assembly. In addition, asecond feedback loop in the control system 25 maintains the electricalcurrent supplied to the acoustic assembly at a pre-selected constantlevel in order to achieve substantially constant excursion at the endeffector 18 of the acoustic assembly. In yet another embodiment, a thirdfeedback loop in the control system 25 monitors impedance betweenelectrodes located in the end effector assembly 26.

In ultrasonic operation mode, the electrical signal supplied to theacoustic assembly may cause the distal end of the end effector 18, tovibrate longitudinally in the range of, for example, approximately 20kHz to 250 kHz. According to various embodiments, the blade 66 mayvibrate in the range of about 54 kHz to 56 kHz, for example, at about55.5 kHz. In other embodiments, the blade 66 may vibrate at otherfrequencies including, for example, about 31 kHz or about 80 kHz. Theexcursion of the vibrations at the blade 66 can be controlled by, forexample, controlling the amplitude of the electrical signal applied tothe transducer assembly of the acoustic assembly by the generator 20. Asnoted above, the triggering mechanism of the generator 20 allows a userto activate the generator 20 so that electrical energy may becontinuously or intermittently supplied to the acoustic assembly. Thegenerator 20 also has a power line for insertion in an electro-surgicalunit or conventional electrical outlet. It is contemplated that thegenerator 20 can also be powered by a direct current (DC) source, suchas a battery. The generator 20 can comprise any suitable generator, suchas Model No. GEN04, and/or Model No. GEN11 available from EthiconEndo-Surgery, Inc.

In various instances, when the acoustic assembly is energized, avibratory motion standing wave is generated through the acousticassembly. The amplitude of the vibratory motion at any point along theacoustic assembly depends on the location along the acoustic assembly atwhich the vibratory motion is measured. A minimum or zero crossing inthe vibratory motion standing wave is generally referred to as a node(i.e., where motion is usually minimal), and an absolute value maximumor peak in the standing wave is generally referred to as an anti-node.

FIG. 2 is a left perspective view of one example embodiment of theultrasonic surgical instrument 10 showing the handle assembly 12, thedistal rotation assembly 13, the elongated shaft assembly 14, and theend effector assembly 26. In the illustrated embodiment the elongatedshaft assembly 14 comprises a distal end 52 dimensioned to mechanicallyengage the end effector assembly 26 and a proximal end 50 thatmechanically engages the handle assembly 12 and the distal rotationassembly 13. The proximal end 50 of the elongated shaft assembly 14 isreceived within the handle assembly 12 and the distal rotation assembly13.

In the illustrated embodiment, the trigger assembly 24 comprises atrigger 32 that operates in conjunction with a fixed handle 34. Thefixed handle 34 and the trigger 32 are ergonomically formed and adaptedto interface comfortably with the user. The fixed handle 34 isintegrally associated with the handle assembly 12. The trigger 32 ispivotally movable relative to the fixed handle 34 as explained in moredetail below with respect to the operation of the ultrasonic surgicalinstrument 10. The trigger 32 is pivotally movable in direction 33Atoward the fixed handle 34 when the user applies a squeezing forceagainst the trigger 32. A spring element may cause the trigger 32 topivotally move in direction 33B when the user releases the squeezingforce against the trigger 32.

In one example embodiment, the trigger 32 comprises an elongated triggerhook 36, which defines an aperture 38 between the elongated trigger hook36 and the trigger 32. The aperture 38 is suitably sized to receive oneor multiple fingers of the user therethrough. The trigger 32 also maycomprise a resilient portion 32 a molded over the trigger 32 substrate.The overmolded resilient portion 32 a is formed to provide a morecomfortable contact surface for control of the trigger 32 in outwarddirection 33B. In one example embodiment, the overmolded resilientportion 32 a may be provided over a portion of the elongated triggerhook 36. The proximal surface of the elongated trigger hook 32 remainsuncoated or coated with a non-resilient substrate to enable the user toeasily slide their fingers in and out of the aperture 38. In anotherembodiment, the geometry of the trigger forms a fully closed loop whichdefines an aperture suitably sized to receive one or multiple fingers ofthe user therethrough. The fully closed loop trigger also may comprise aresilient portion molded over the trigger substrate.

In one example embodiment, the fixed handle 34 comprises a proximalcontact surface 40 and a grip anchor or saddle surface 42. The saddlesurface 42 rests on the web where the thumb and the index finger arejoined on the hand. The proximal contact surface 40 has a pistol gripcontour that receives the palm of the hand in a normal pistol grip withno rings or apertures. The profile curve of the proximal contact surface40 may be contoured to accommodate or receive the palm of the hand. Astabilization tail 44 is located towards a more proximal portion of thehandle assembly 12. The stabilization tail 44 may be in contact with theuppermost web portion of the hand located between the thumb and theindex finger to stabilize the handle assembly 12 and make the handleassembly 12 more controllable.

In one example embodiment, the switch assembly 28 may comprise a toggleswitch 30. The toggle switch 30 may be implemented as a single componentwith a central pivot 304 located within inside the handle assembly 12 toeliminate the possibility of simultaneous activation. In one exampleembodiment, the toggle switch 30 comprises a first projecting knob 30 aand a second projecting knob 30 b to set the power setting of theultrasonic transducer 16 between a minimum power level (e.g., MIN) and amaximum power level (e.g., MAX). In another embodiment, the rockerswitch may pivot between a standard setting and a special setting. Thespecial setting may allow one or more special programs to be implementedby the device. The toggle switch 30 rotates about the central pivot asthe first projecting knob 30 a and the second projecting knob 30 b areactuated. The one or more projecting knobs 30 a, 30 b are coupled to oneor more arms that move through a small arc and cause electrical contactsto close or open an electric circuit to electrically energize orde-energize the ultrasonic transducer 16 in accordance with theactivation of the first or second projecting knobs 30 a, 30 b. Thetoggle switch 30 is coupled to the generator 20 to control theactivation of the ultrasonic transducer 16. The toggle switch 30comprises one or more electrical power setting switches to activate theultrasonic transducer 16 to set one or more power settings for theultrasonic transducer 16. The forces required to activate the toggleswitch 30 are directed substantially toward the saddle point 42, thusavoiding any tendency of the instrument to rotate in the hand when thetoggle switch 30 is activated.

In one example embodiment, the first and second projecting knobs 30 a,30 b are located on the distal end of the handle assembly 12 such thatthey can be easily accessible by the user to activate the power withminimal, or substantially no, repositioning of the hand grip, making itsuitable to maintain control and keep attention focused on the surgicalsite (e.g., a monitor in a laparoscopic procedure) while activating thetoggle switch 30. The projecting knobs 30 a, 30 b may be configured towrap around the side of the handle assembly 12 to some extent to be moreeasily accessible by variable finger lengths and to allow greaterfreedom of access to activation in awkward positions or for shorterfingers.

In the illustrated embodiment, the first projecting knob 30 a comprisesa plurality of tactile elements 30 c, e.g., textured projections or“bumps” in the illustrated embodiment, to allow the user todifferentiate the first projecting knob 30 a from the second projectingknob 30 b. It will be appreciated by those skilled in the art thatseveral ergonomic features may be incorporated into the handle assembly12. Such ergonomic features are described in U.S. Pat. App. Pub. No.2009/0105750 entitled “Ergonomic Surgical Instruments” which isincorporated by reference herein in its entirety.

In one example embodiment, the toggle switch 30 may be operated by thehand of the user. The user may easily access the first and secondprojecting knobs 30 a, 30 b at any point while also avoiding inadvertentor unintentional activation at any time. The toggle switch 30 mayreadily operated with a finger to control the power to the ultrasonicassembly 16 and/or to the ultrasonic assembly 16. For example, the indexfinger may be employed to activate the first contact portion 30 a toturn on the ultrasonic assembly 16 to a maximum (MAX) power level. Theindex finger may be employed to activate the second contact portion 30 bto turn on the ultrasonic assembly 16 to a minimum (MIN) power level. Inanother embodiment, the rocker switch may pivot the instrument 10between a standard setting and a special setting. The special settingmay allow one or more special programs to be implemented by theinstrument 10. The toggle switch 30 may be operated without the userhaving to look at the first or second projecting knob 30 a, 30 b. Forexample, the first projecting knob 30 a or the second projecting knob 30b may comprise a texture or projections to tactilely differentiatebetween the first and second projecting knobs 30 a, 30 b withoutlooking.

In one example embodiment, the distal rotation assembly 13 is rotatablewithout limitation in either direction about a longitudinal axis “T.”The distal rotation assembly 13 is mechanically engaged to the elongatedshaft assembly 14. The distal rotation assembly 13 is located on adistal end of the handle assembly 12. The distal rotation assembly 13comprises a cylindrical hub 46 and a rotation knob 48 formed over thehub 46. The hub 46 mechanically engages the elongated shaft assembly 14.The rotation knob 48 may comprise fluted polymeric features and may beengaged by a finger (e.g., an index finger) to rotate the elongatedshaft assembly 14. The hub 46 may comprise a material molded over theprimary structure to form the rotation knob 48. The rotation knob 48 maybe overmolded over the hub 46. The hub 46 comprises an end cap portion46 a that is exposed at the distal end. The end cap portion 46 a of thehub 46 may contact the surface of a trocar during laparoscopicprocedures. The hub 46 may be formed of a hard durable plastic such aspolycarbonate to alleviate any friction that may occur between the endcap portion 46 a and the trocar. The rotation knob 48 may comprise“scallops” or flutes formed of raised ribs 48 a and concave portions 48b located between the ribs 48 a to provide a more precise rotationalgrip. In one example embodiment, the rotation knob 48 may comprise aplurality of flutes (e.g., three or more flutes). In other embodiments,any suitable number of flutes may be employed. The rotation knob 48 maybe formed of a softer polymeric material overmolded onto the hardplastic material. For example, the rotation knob 48 may be formed ofpliable, resilient, flexible polymeric materials including Versaflex®TPE alloys made by GLS Corporation, for example. This softer overmoldedmaterial may provide a greater grip and more precise control of themovement of the rotation knob 48. It will be appreciated that anymaterials that provide adequate resistance to sterilization, arebiocompatible, and provide adequate frictional resistance to surgicalgloves may be employed to form the rotation knob 48.

In one example embodiment, the handle assembly 12 is formed from two (2)housing portions or shrouds comprising a first portion 12 a and a secondportion 12 b. The first and second portions 12 a and 12 b (as well asthe other components described below) may be assembled together in anyfashion known in the art. For example, alignment pins, snap-likeinterfaces, tongue and groove interfaces, locking tabs, adhesive ports,may all be utilized either alone or in combination for assemblypurposes.

Referring to FIGS. 1-2A, the elongated shaft assembly 14 comprises aproximal end 50 adapted to mechanically engage the handle assembly 12and the distal rotation assembly 13, and a distal end 52 adapted tomechanically engage the end effector assembly 26. The elongated shaftassembly 14 comprises an outer tubular sheath 56 and a reciprocatingtubular actuating member 58 located within the outer tubular sheath 56.The proximal end of the tubular reciprocating tubular actuating member58 is mechanically engaged to the trigger 32 of the handle assembly 12to move in either direction 60A or 60B in response to the actuationand/or release of the trigger 32. The pivotably moveable trigger 32 maygenerate reciprocating motion along the longitudinal axis “T.” Suchmotion may be used, for example, to actuate the jaws or clampingmechanism of the end effector assembly 26. A series of linkagestranslate the pivotal rotation of the trigger 32 to axial movement of ayoke coupled to an actuation mechanism, which controls the opening andclosing of the jaws of the clamping mechanism of the end effectorassembly 26. The distal end of the tubular reciprocating tubularactuating member 58 is mechanically engaged to the end effector assembly26. In the illustrated embodiment, the distal end of the tubularreciprocating tubular actuating member 58 is mechanically engaged to aclamp member 64, which is pivotable about a pivot point 70, to open andclose the clamp member 64 in response to the actuation and/or release ofthe trigger 32. For example, in the illustrated embodiment, the clampmember 64 is movable in direction 62A from an open position to a closedposition about a pivot point 70 when the trigger 32 is squeezed indirection 33A. The clamp member 64 is movable in direction 62B from aclosed position to an open position about the pivot point 70 when thetrigger 32 is released or outwardly contacted in direction 33B.

In one example embodiment, the end effector assembly 26 is attached atthe distal end 52 of the elongated shaft assembly 14 and includes aclamp member 64 and a blade 66. The jaws of the clamping mechanism ofthe end effector assembly 26 are formed by clamp member 64 and the blade66. The blade 66 is ultrasonically actuatable and is acousticallycoupled to the ultrasonic transducer 16. The trigger 32 on the handleassembly 12 is ultimately connected to a drive assembly, which together,mechanically cooperate to effect movement of the clamp member 64.Squeezing the trigger 32 in direction 33A moves the clamp member 64 indirection 62A from an open position, wherein the clamp member 64 and theblade 66 are disposed in a spaced relation relative to one another, to aclamped or closed position, wherein the clamp member 64 and the blade 66cooperate to grasp tissue therebetween. The clamp member 64 may comprisea clamp pad to engage tissue between the blade 66 and the clamp member64. Releasing the trigger 32 in direction 33B moves the clamp member 64in direction 62B from a closed relationship, to an open position,wherein the clamp member 64 and the blade 66 are disposed in a spacedrelation relative to one another.

The proximal portion of the handle assembly 12 comprises a proximalopening 68 to receive the distal end of the ultrasonic assembly 16. Theultrasonic assembly 16 is inserted in the proximal opening 68 and ismechanically engaged to the elongated shaft assembly 14.

Referring now to FIGS. 3-5, in certain instances, the surgicalinstrument 10 may include an elongated shaft assembly 114, which issimilar in many respects to the elongated shaft assembly 14. Inaddition, as illustrated in FIG. 3, the surgical instrument 10 mayinclude an end effector assembly 126, which is similar in many respectsto the end effector assembly 26, for example. In certain instances, theend effector assembly 126 may include a clamp member 164, for example.In certain instances, the elongated shaft assembly 114 may include anouter tubular reciprocating member 156 and an inner tubular member 158,for example. In certain instances, the outer tubular reciprocatingmember 156 and the inner tubular member 158 may extend coaxially alongthe longitudinal axis “T”, for example. In certain instances, the innertubular member 158 may be partially surrounded by the outer tubularreciprocating member 156, for example. In certain instances, the blade66 may extend through the inner tubular member 158; the inner tubularmember 158 can be configured to receive the blade 66.

In certain instances, the blade 66 can be cooperatively coupled to theinner tubular member 158, for example. In certain instances, a sealingmember 131 (FIG. 4) can be disposed between the blade 66 and innertubular member 158, and may resist fluid entry into the elongated shaftassembly 114, for example. In certain instances, the sealing member 131can be disposed around, or at least partially around, the blade 66, forexample. In certain instances, the sealing member 131 may be positionedat or adjacent to a distal node of vibration. In certain instances, thesealing member 131 may be positioned at or adjacent to a node closest tothe distal end of the blade 66, for example. In various instances, thesealing member 131 may comprise a sealing lip or a ring disposed aroundthe blade 66, for example.

In certain instances, the outer tubular reciprocating member 156 can beaxially movable relative to the inner tubular member 158. For example,the outer tubular reciprocating member 156 can be retracted proximallyand/or advanced distally relative to the inner tubular member 158. Incertain instances, the ultrasonic blade 66 can be coupled to the innertubular member 158. In such instances, the outer tubular reciprocatingmember 156 can be retracted proximally and/or advanced distally relativeto the blade 66 and the inner tubular member 158, for example.

A proximal portion of the outer tubular reciprocating member 156 can beoperably coupled to the trigger 32 of the handle assembly 12 to move ineither direction 160A or 1608 in response to the actuation and/orrelease of the trigger 32. A distal portion 127 of the outer tubularreciprocating member 156 can be movably coupled to the end effectorassembly 126. In at least one example, the distal portion 127 of theouter tubular reciprocating member 156 can be pivotably coupled to theclamp member 164. Reciprocating the outer tubular reciprocating member156 between a first or retracted position and a second or advancedposition may cause the clamp member 164 to be transitioned between anapproximated configuration and an open configuration with the ultrasonicblade 66, for example. FIG. 3, for example, illustrates the clamp member164 in a partially open configuration with respect to the blade 66.

In certain instances, the clamp member 164 may be pivotably coupled tothe outer tubular reciprocating member 156 at a pivot point defined bypivot pins 170 (FIG. 5) which can be received in designated slots 171(FIG. 4) on the distal portion 127 of the outer tubular reciprocatingmember 156, for example. In such instances, the clamp member 164 can bepivoted about the pins 170, in response to the reciprocating motion ofthe outer tubular reciprocating member 156, to transition between theapproximated configuration and the open configuration with respect tothe blade 66.

Further to the above, the clamp member 164 can also be pivotably coupledto the inner tubular member 158, and can be configured to pivot relativeto the inner tubular member 158 in response to the reciprocating motionof the outer tubular reciprocating member 156, for example. In certaininstances, the inner tubular member 158 may comprise a connection member157 disposed at a distal end portion of the inner tubular member 158, asillustrated in FIG. 3. In certain instances, the clamp member 164 can bepivotably coupled to the connection member 157. For example, a pivot pin159 may extend through openings 161 of the clamp member 164 and throughthe connection member 157 to pivotably couple the clamp member 164 tothe connection member 157.

In any event, reciprocating the outer tubular reciprocating member 156between the first position and the second position may cause the clampmember 164 to pivot about the pin 159 and the pins 170 to transitionbetween the open configuration and the approximated configuration withrespect to the blade 66, for example. In certain instances, the pin 159,which couples the clamp member 164 to the connection member 157, and thepins 170, which couple the clamp member 164 to the distal portion 127 ofthe outer tubular reciprocating member 156, may reside on opposite sidesof the blade 66, as illustrated in FIG. 3. In other words, the blade 66can be disposed between the distal portion 127 and the blade 66.

In certain instances, as illustrated in FIG. 3, the blade 66 may extendbetween the distal portion 127 of the outer tubular reciprocating member156 and the connection member 157. The distal portion 127 may bepartially open which may expose, or partially expose, the connectionmember 157, for example. In certain instances, the side of theconnection member 157 may comprise a shape that complements the blade66, for example.

In certain instances, the connection member 157 can be manufactured withthe inner tubular member 158 as a single unit. For example, theconnection member 157 and the inner tubular member 158 can be injectionmolded together as a single unit. In other instances, the connectionmember 157 and the inner tubular member 158 can be manufacturedseparately and attached together during assembly of the surgicalinstrument 10. In at least one example, the connection member 157 andthe inner tubular member 158 may comprise complimentary portions 165 and167, respectively, which can be welded together, for example, to attachthe connection member 157 to the inner tubular member 158. Othermechanisms for manufacturing and/or attaching the inner tubular member158 and the connection member 157 are contemplated by the presentdisclosure. The reader will appreciate that manufacturing of theconnection member 157 separately may ensure a greater accuracy in thedimensions of the connection member 157, which may lead to a betteralignment between the clamp member 164 and the blade 66 during assemblyof the surgical instrument 10.

In certain instances, as illustrated in FIG. 4, the connection member157 may comprise a greater thickness than the wall of the inner tubularmember 158. The increased thickness of the connection member 157 mayprovide stability to the clamp member 164 during the transition betweenthe open configuration and the approximated configuration. In addition,the increased thickness of the connection member 157 may providesufficient space for a through-hole 169 for receiving the pin 159, forexample.

Further to the above, the present disclosure provides a method forassembling a surgical instrument such as, for example, the surgicalinstrument 10. In certain instances, the method for assembling thesurgical instrument 10 may ensure proper alignment between the blade 66and the clamp member 164. The reader will appreciate that it can bedesirable to accurately align the clamp member 164 with the blade 66 toensure proper transmission of ultrasonic energy through the blade 66 totissue captured between the clamp member 164 and the blade 66 in theapproximated configuration. In certain instances, it can be desirablefor the clamp member 164 to be rotationally aligned with the blade 66,for example, to ensure that a curvature of the clamp member 164 isaligned with a curvature of the blade 66, for example. In certaininstances, it can be desirable for a distal end 66 a of the blade 66 tobe axially aligned with a distal end 164 a of the clamp member 164, forexample.

In any event, the method for assembling the surgical instrument 10 maycomprise the steps of: positioning the blade 66 with respect to theinner tubular member 158, positioning the inner tubular member 158 withrespect to the outer tubular reciprocating member 156, coupling theclamp member 164 to the outer tubular reciprocating member 156, couplingthe clamp member 164 to the connection member 157, and/or attaching theconnection member 157 to the inner tubular member 158, for example. Thereader will appreciate that reserving the attachment of the connectionmember 157 to the inner tubular member 158 until the assembly stage canfacilitate fine adjustment of the relative positions of the clamp member164 and the connection member 157 thereby ensuring the proper rotationaland axial alignment between the blade 66 and the clamp member 164.

Referring now to FIGS. 6-9, the surgical instrument 10 may include anelongated shaft assembly 214. FIG. 6 illustrates a partialcross-sectional view of the elongated shaft assembly 214. The elongatedshaft assembly 214 is similar in many respects to the elongated shaftassembly 14 and/or the elongated shaft assembly 114. In certaininstances, the elongated shaft assembly 214 can be adapted for couplingengagement with the end effector assembly 26 to actuate the clamp member64 in a similar manner to the elongated shaft assembly 14, for example.In certain instances, the elongated shaft assembly 214 can be adaptedfor coupling engagement with the end effector assembly 126 to actuatethe clamp member 164 in a similar manner to the elongated shaft assembly114, for example.

In any event, the elongated shaft assembly 214 may include an outer tube256, which is similar in many respects to the outer tubular member 56and/or the outer tubular member 156, for example. In addition, theelongated shaft assembly 214 may include an inner tube 258, which issimilar in many respects to the inner tubular member 58 and/or the innertubular member 158, for example. Furthermore, the elongated shaftassembly 214 may include an ultrasonic blade 266, which is similar inmany respects to the ultrasonic blade 66. For example, like theultrasonic blade 66, the ultrasonic blade 266 can be acousticallycoupled to the transducer 16.

In various instances, in an exemplary assembled form of the surgicalinstrument 10, the outer tube 256 and the inner tube 258 may extendcoaxially along a longitudinal axis “T”, as illustrated in FIG. 6A. Incertain instances, the inner tube 258 may be partially surrounded by theouter tube 256, for example. In certain instances, the blade 266 mayextend through the inner tube 258; the inner tube 258 can be configuredto receive the blade 266. In certain instances, the blade 266 can becooperatively coupled to the inner tube 258, for example.

As described above, rotational and/or axial positioning and/or alignmentof an ultrasonic blade such as, for example, the ultrasonic blade 266with respect to other components of the surgical instrument 10 can beimportant in ensuring proper performance of the surgical instrument 10including but not limited to efficient transmission of the ultrasonicenergy. In various instances, the inner tube 258 and/or the blade 266may include one or more alignment features, which may establish therotational and/or axial positioning and/or alignment of the blade 266with respect to other components of the surgical instrument 10 andmaintain such rotational and/or axial positioning and/or alignmentduring use of the surgical instrument 10 in a surgical procedure, forexample. In at least one example, as illustrated in FIG. 6, the innertube 258 may comprise an alignment feature 258 a, and the blade 266 maycomprise an alignment feature 266 a.

In various instances, referring primarily to FIGS. 6 and 8, thealignment features 258 a and/or 266 a may be positioned at a node ofvibration along the blade 266. As described above, a minimum or zerocrossing in the vibratory motion may exist at a node of vibration;positioning the alignment features 258 a and/or 266 a at the node ofvibration may reduce interference with the operation of the blade 266,which may increase the efficiency of the ultrasonic energy transmission,for example. In certain instances, the alignment features 258 a and/or266 a may be positioned at a distal node of vibration. In certaininstances, the alignment features 258 a and/or 266 a may be positionedat a node closest to the distal end of the blade 266, for example.

In various instances, referring to FIGS. 6-9, the alignment feature 258a and/or the alignment feature 266 a may comprise one or more vibrationisolating portions 259 such as, for example, an overmolded siliconerubber bushing. In various instances, the vibration isolating portions259 can be overmolded onto the blade 266 and/or the inner tube 258, forexample. In certain instances, the vibration isolating portions 259 canbe integrated with the sealing member 131, as illustrated in FIG. 6.

In certain instances, as illustrated in FIG. 6A, the alignment feature266 a of the blade 266 may comprise a receiving portion 266 c, which canbe adapted to receive a constraining member 258 c of the alignmentfeature 258 a of the inner tube 258, for example. In certain instances,the receiving portion 266 c can be interfaced with the constrainingmember 258 c to establish rotational and/or axial positioning and/oralignment of the blade 266 with respect to other components of thesurgical instrument 10 and maintain such rotational and/or axialpositioning and/or alignment during use of the surgical instrument 10 ina surgical procedure, for example. As illustrated in FIG. 6A, thereceiving portion 266 c may be comprised of a slot, a notch, a groove,an aperture, and/or a gap in the body of the blade 266, which can beadapted for mating engagement with the constraining member 258 c, forexample. For example, the constraining member 258 c may comprise a tab,a tongue or a latch, which can be inserted into a socket of thereceiving portion 266 c to establish rotational and/or axial positioningand/or alignment of the blade 266 with respect to other components ofthe surgical instrument 10 and maintain such rotational and/or axialpositioning and/or alignment during use of the surgical instrument 10 ina surgical procedure, for example. In certain instances, as illustratedin FIG. 10, the alignment feature 258 a may comprise a flat section 258b which can be aligned with a corresponding flat section 266 b of theblade 266 to establish rotational alignment between the blade 266 andthe inner tube 258 and maintain such alignment during use of thesurgical instrument 10 in a surgical procedure, for example.

Referring to FIG. 7, in certain instances, the inner tube 258 maycomprise a side opening 272 in a wall of the inner tube 258, forexample. In certain instances, the constraining member 258 c can beinterfaced with the receiving portion 266 c by inserting at least aportion of the constraining member 258 c through the side opening 272 ofthe inner tube 258 into engagement with the receiving portion 266 c, forexample. In certain instances, the blade 266 can be inserted into theinner tube 258 and aligned therewith such that the receiving portion 266c is faced with the side opening 272 of the inner tube. The constrainingmember 258 c can then be inserted, or at least partially inserted,through the side opening 272 of the inner tube 258 and into engagementwith the receiving portion 266 c, which may establish and maintainrotational and/or axial positioning and/or alignment between the blade266 with the inner tube 258, for example. In certain instances, theconstraining member 258 c may be fixedly attached to the inner tube 258at the side opening 272, for example. In certain instances, theconstraining member 258 c can be welded to the wall of the inner tube258 at the side opening 272, for example. In certain instances, theconstraining member 258 c can be assembled with the inner tube 258through a snap-like interface, locking tabs, and/or an adhesive, forexample. In at least one example, the constraining member 258 c maycomprise a c-clip or a pin which can be welded to the inner tube 258,for example.

Referring mainly to FIGS. 11 and 12, in certain instances, the sealingmember 131 may comprise an alignment feature 131 a, which is similar inmany respects to the alignment feature 266 a of the blade 266. Forexample, the alignment feature 131 a can be employed in a similar mannerto the alignment feature 266 a in establishing and maintaining therotational and/or axial positioning and/or alignment of the blade 266with respect to other components of the surgical instrument 10. Incertain instances, the alignment feature 131 a may comprise a receivingportion 131 c similar to the receiving portion 266 c, which can beadapted to receive constraining member 258 c. In certain instances, thealignment feature 131 a may comprise a flat section 131 b that issimilar in many respects to the flat section 266 b of the alignmentfeature 266 a. In certain instances, the flat section 131 b can beadapted for interfacing with the flat section 258 b of the inner tube258, as illustrated in FIG. 12.

In certain instances, as illustrated in FIGS. 11 and 12, the alignmentfeature 258 a of the inner tube 258 can be positioned at a distalportion of the inner tube 258. In certain instances, the inner tube 258may comprise a retaining cap 258 d at a distal portion of the inner tube258. In certain instances, the alignment feature 258 a may be positionedat an inner wall of the retaining cap 258 d, for example. In certaininstances, as illustrated in FIG. 12, the retaining cap 258 d maycomprise the side opening 272, for example. A constraining member suchas, for example, the constraining member 258 c can be interfaced withthe receiving portion 131 c by inserting at least a portion of theconstraining member 258 c through the side opening 272 of the retainingcap 258 d to engage the receiving portion 131 c, for example.

In various instances, the sealing member 131 can be coupled to the blade266. For example, the sealing member 131 can be snuggly fitted around,or at least partially around, the blade 266, as illustrated in FIG. 12.In such instances, interfacing the alignment feature 131 a of thesealing member 131 with the alignment feature 258 a of the retaining cap258 d may establish and maintain rotational and/or axial positioningand/or alignment between the sealing member 131 and the retaining cap258 d, which in turn may establish and maintain the rotational and/oraxial positioning and/or alignment between the blade 266 and the innertube 258, for example.

In various instances, referring primarily to FIG. 13, the elongatedshaft assembly 214 may comprise an insert 274, which can be positionedbetween the inner tube 258 and the blade 266. In certain instances, theinsert 274 may comprise a plurality of flat sections 274 a-274 c, whichcan be adapted to interface with a plurality of corresponding flatsections 266 d-266 f on the blade 266, as illustrated in FIG. 13. Suchan arrangement may establish and maintain rotational positioning and/oralignment between the insert 274 and the blade 266, which in turn mayestablish and maintain the rotational positioning and/or alignmentbetween the blade 266 and the inner tube 258, for example.

In certain instances, the insert 274 can be fixedly attached to theinner tube 258. In at least one example, the insert 274 can be welded tothe inner tube 258. In such instances, the insert 274 can be positionedin place between the blade 266 and the inner tube 258 during assembly ofthe surgical instrument 10. Once the rotational positioning and/oralignment between the insert 274 and the blade 266 is adjusted to adesired degree, the insert 274 can be welded to the inner tube 258 tomaintain such rotational positioning and/or alignment, for example.

In certain instances, the insert 274 can be positioned at or adjacent toa distal node of vibration. In certain instances, the insert 274 may bepositioned at a node closest to the distal end of the blade 266, forexample. In at least one example, the insert 274 may comprise a singleflat wall insertable between the blade 266 and the inner tube 258. In atleast one example, the insert 274 may comprise two flat walls insertablebetween the blade 266 and the inner tube 258. The flat walls mayintersect at a perpendicular, or at least substantially perpendicular,angle and. In at least one example, as illustrated in FIG. 13, theinsert 274 may comprise three flat walls insertable between the blade266 and the inner tube 258.

In various instances, referring primarily to FIG. 14, the elongatedshaft assembly 214 can be modified by replacing the inner tube 258 witha channel 258′ which, in certain instances, may comprise a semi-circulartransverse cross-section, for example. In various instances, a blade266′, which is similar in many respects to the blade 266, can beassembled with the channel 258′. As illustrated in FIG. 15, the channel258′ and the blade 266′ may comprise complimenting alignment features276 and 278, respectively. In various instances, the alignment features276 and 278 can be similar in many respects to the alignment features258 a and 266 a, for example. In certain instances, the alignmentfeatures 276 and 278 can be interfaced to establish and maintainrotational and/or axial positioning and/or alignment between the channel258′ and the blade 266′, for example.

In certain instances, as illustrated in FIG. 15, the alignment feature276 of the channel 258′ may comprise one or more divots 276 a. Incertain instances, each divot 276 a can be received between two divots278 a of the alignment feature 278 of the blade 266′, for example. Thedivots 276 a and 278 a can cooperate to establish and maintainrotational and/or axial positioning and/or alignment between the channel258′ and the blade 266′, for example, and maintain such to establish andmaintain rotational and/or axial positioning and/or alignment during useof the surgical instrument 10 in a surgical procedure.

In certain instances, the alignment features 276 and 278 may comprisecomplimenting flat sections which can be interfaced to establish andmaintain rotational positioning and/or alignment between the channel258′ and the blade 266′, for example. In at least one example, thealignment feature 276 may comprise three flat sections 276 b which canbe disposed on three inner walls of the channel 258′, as illustrated inFIG. 14. In addition, the blade 266′ may comprise three flat sections278 b for mating engagement with the flat sections 276 b, for example.In various instances, the alignment features 276 and/or 278 can bepositioned at or adjacent to one or more nodes of vibration. In certaininstances, the alignment features 276 and/or 278 may be positioned atone or more nodes of vibration at a distal portion of the blade 266, forexample.

In various instances, as illustrated in FIG. 6, the elongated shaftassembly 214 can be adapted for coupling engagement with the endeffector assembly 26 to actuate the clamp member 64 between an openconfiguration and an approximated configuration to capture tissuebetween the clamp member 64 and the blade 266, for example. In suchinstances, the clamp member 64 can be actuated to generate a clampingforce against the blade 266. In various instances, the elongated shaftassembly 214 can be adapted for coupling engagement with the endeffector assembly 126 to actuate the clamp member 164 between an openconfiguration and an approximated configuration to capture tissuebetween the clamp member 164 and the blade 266, for example. In suchinstances, the clamp member 164 can be actuated to generate a clampingforce against the blade 266.

In certain instances, the clamping force generated by the clamp member164 or the clamp member 64 can be applied along a vector whichintersects a plane P defined by the flat section 266 b of the blade 266,for example. In certain instances, the vector of the generated clampingforce may form a perpendicular, or at least substantially perpendicular,angle with the plane P, for example. In certain instances, the anglebetween the vector of the generated clamping force and the plane Pdefined by the flat section 266 b of the blade 266 can be any valueselected from a range of about 85 degrees to about 95 degrees. Incertain instances, the angle between the vector of the generatedclamping force and the plane P defined by the flat section 266 b of theblade 266 can be any value selected from a range of about 89 degrees toabout 91 degrees. In certain instances, the angle between the vector ofthe generated clamping force and the plane P defined by the flat section266 b of the blade 266 can be about 90 degrees.

In various instances, as illustrated in FIG. 6, the clamp member 64 ofthe end effector assembly 26 can be moved between the open configurationand the closed configuration along, or at least substantially along, aplane P1 intersecting the plane P defined by the flat section 266 b ofthe blade 266. In certain instances, the plane P1 can be perpendicular,or at least substantially perpendicular, with the plane P. In certaininstances, the angle between the plane P1 and the plane P is any angleselected from a range of about 85 degrees to about 95 degrees. Incertain instances, the angle between the plane P1 and the plane P is anyangle selected from a range of about 89 degrees to about 91 degrees.

Similarly, the clamp member 164 of the end effector assembly 126 can bemoved between the open configuration and the closed configuration along,or at least substantially along, a plane P2 intersecting the plane Pdefined by the flat section 266 b of the blade 266. In certaininstances, the plane P2 can be perpendicular, or at least substantiallyperpendicular, with the plane P. In certain instances, the angle betweenthe plane P2 and the plane P is any angle selected from a range of about85 degrees to about 95 degrees. In certain instances, the angle betweenthe plane P2 and the plane P is any angle selected from a range of about89 degrees to about 91 degrees.

In various instances, as illustrated in FIG. 6, the clamp member 64 ofthe end effector assembly 26 and the flat section 258 b of the innertube 258 can be disposed on opposite sides of the plane P defined by theflat section 266 b of the blade 266. In such instances, the clampingforce generated by the clamp member 64 may bias, motivate, and/or movethe alignment feature 266 a of the blade 266 toward the alignmentfeature 258 a of the inner tube 258. In certain instances, the clampingforce generated by the clamp member 64 may bring the alignment feature266 a of the blade 266 into contact with the alignment feature 258 a ofthe inner tube 258.

Similarly, the clamp member 164 of the end effector assembly 126 and theflat section 258 b of the inner tube 258 can be disposed on oppositesides of the plane P defined by the flat section 266 b of the blade 266.In such instances, the clamping force generated by the clamp member 164may bias, motivate, and/or move the alignment feature 266 a of the blade266 toward the alignment feature 258 a of the inner tube 258. In certaininstances, the clamping force generated by the clamp member 164 maybring the alignment feature 266 a of the blade 266 into contact with thealignment feature 258 a of the inner tube 258.

Referring now to FIGS. 16-20, an ultrasonic surgical instrument 310 isdepicted. The surgical instrument 310 is similar in many respects to thesurgical instrument 10. For example, the instrument 310 includes anultrasonic blade 366, which is similar in many respects to theultrasonic blade 66. Like the blade 66, the blade 366 can beacoustically coupled to the ultrasonic transducer 16, for example.Furthermore, the instrument 310 may include a clamp member 364, which issimilar in many respects to the clamp member 64 and/or the clamp member164, for example.

In various instances, the surgical instrument 310 can be employed inopen surgery. In certain instances, the clamp member 364 can betransitioned between an approximated configuration and an openconfiguration with respect to the ultrasonic blade 366 by actuating ahandle 301, for example. In certain instances, the clamp member 364 maybe pivotably coupled to a support shaft 358 at a pivot point 370. Insuch instances, the clamp member 364 can be pivoted about the point 370by actuating the handle 301. The blade 366 may extend through thesupport shaft 358; the support shaft 358 can be configured to receivethe blade 266.

In various instances, rotational and/or axial positioning and/oralignment of an ultrasonic blade such as, for example, the ultrasonicblade 366 with respect to other components of the surgical instrument310 can be important in ensuring proper performance of the surgicalinstrument 310 including but not limited to efficient transmission ofthe ultrasonic energy. In various instances, the support shaft 358and/or the blade 366 may include one or more alignment features, whichmay establish the rotational and/or axial positioning and/or alignmentof the blade 366 with respect to other components of the surgicalinstrument 310. The alignment features can also maintain the rotationaland/or axial positioning and/or alignment during use of the surgicalinstrument 310 in a surgical procedure, for example. In at least oneexample, as illustrated in FIG. 17, the support shaft 358 may comprisean alignment feature 358 a, and the blade 366 may comprise an alignmentfeature 366 a.

In various instances, referring primarily to FIGS. 16-18, the alignmentfeatures 358 a and/or 366 a may be positioned at a node of vibrationalong the blade 366. As described above, a minimum or zero crossing inthe vibratory motion may exist at a node of vibration; positioning thealignment features 358 a and/or 366 a at the node of vibration mayreduce interference with the operation of the blade 366, which mayincrease the efficiency of the ultrasonic energy transmission, forexample. In certain instances, the alignment features 358 a and/or 366 amay be positioned at a distal node of vibration. In certain instances,the alignment features 358 a and/or 366 a may be positioned at a nodeclosest to the distal end of the blade 366, for example.

In various instances, referring to FIGS. 16-18, the alignment feature358 a and/or the alignment feature 366 a may comprise one or morevibration isolating portions 259 such as, for example, an overmoldedsilicone rubber bushing. In various instances, the vibration isolatingportions 259 can be overmolded onto the blade 366 and/or the supportshaft 358, for example. In certain instances, the vibration isolatingportions 259 can be integrated with the sealing member 131. Asillustrated in FIG. 17, the sealing member 131 can be disposed betweenthe blade 366 and support shaft 358. In certain instances, the sealingmember 131 can be disposed around, or at least partially around, theblade 366, for example. In certain instances, the sealing member 131 maybe positioned at or adjacent to a distal node of vibration. In certaininstances, the sealing member 131 may be positioned at or adjacent to anode closest to the distal end of the blade 366, for example. In variousinstances, the sealing member 131 may comprise a sealing lip or a ringdisposed around the blade 366, for example.

In certain instances, as illustrated in FIGS. 17-20, the alignmentfeature 358 a may comprise a flat section 358 b which can be alignedwith a corresponding flat section 366 b of the blade 266 to establishrotational alignment between the blade 366 and the support shaft 358 andmaintain such alignment during use of the surgical instrument 310 in asurgical procedure, for example. In certain instances, the greater thesurface areas of the interfacing flat sections 358 b and/or 366 b, themore robust the alignment achieved therebetween. In at least oneexample, one or both of the surface areas of the interfacing flatsections 358 b and/or 366 b may comprise a multilateral shape such as asquare, for example. In at least one example, one or both of the surfaceareas of the interfacing flat sections 358 b and/or 366 b may comprise acircular shape.

In various instances, as described above, the support shaft 358 can bepivotably coupled to the clamp member 364 such that actuation of thehandle 301 may cause the clamp member 364 to transition between an openconfiguration and an approximated configuration to capture tissuebetween the clamp member 364 and the blade 366, for example. In suchinstances, the clamp member 364 may generate a clamping force againstthe blade 366.

In certain instances, the clamping force generated by the clamp member364 can be applied along a vector which intersects a plane P defined bythe flat section 366 b of the blade 366, for example. In certaininstances, the vector of the generated clamping force can form aperpendicular, or at least substantially perpendicular, angle with theplane P, for example. In certain instances, the angle between the vectorof the generated clamping force and the plane P defined by the flatsection 366 b of the blade 366 can be any value selected from a range ofabout 85 degrees to about 95 degrees. In certain instances, the anglebetween the vector of the generated clamping force and the plane Pdefined by the flat section 366 b of the blade 366 can be any valueselected from a range of about 89 degrees to about 91 degrees.

In various instances, as illustrated in FIG. 16, the clamp member 364can be movable between the open configuration and the closedconfiguration along, or at least substantially along, a plane P1intersecting the plane P defined by the flat section 366 b of the blade366. In certain instances, the plane P1 can be perpendicular, or atleast substantially perpendicular with the plane P. In certaininstances, the angle between the plane P1 and the plane P is any angleselected from a range of about 85 degrees to about 95 degrees. Incertain instances, the angle between the plane P1 and the plane P is anyangle selected from a range of about 89 degrees to about 91 degrees.

In various instances, referring primarily to FIGS. 16 and 18, the clampmember 364 and the flat section 358 b of the support shaft 358 can bedisposed on opposite sides of the plane P defined by the flat section366 b of the blade 366, for example. In such instances, the clampingforce generated by the clamp member 364 may bias, motivate, and/or movethe alignment feature 366 a of the blade 266 toward the alignmentfeature 358 a of the support shaft 358. In certain instances, theclamping force generated by the clamp member 364 may bring the alignmentfeature 366 a of the blade 366 into contact with the alignment feature358 a of the inner tube 358. As illustrated in FIG. 17, in certaininstances, a slight rotational misalignment may remain after assembly ofthe surgical instrument 310. Such slight rotational misalignment is,however, corrected when the alignment feature 366 a of the blade 266 isbiased toward the alignment feature 358 a of the support shaft 358 bythe application of the clamping force generated by the clamp member 364against the blade 366, for example.

As described above, the surgical instrument 10 (FIG. 2) may include ahandle assembly such as, for example, the handle assembly 12 (FIG. 2),an end effector assembly such as, for example, the end effector assembly26 (FIG. 2A), and an elongated shaft assembly such as, for example, theelongated shaft assembly 14 (FIG. 2) which extends between the handleassembly 12 and the end effector assembly 26. The handle assembly 12 maybe adapted to receive the ultrasonic transducer 16 at the proximal end.The ultrasonic transducer 16 can be mechanically engaged to theelongated shaft assembly 14 and portions of the end effector assembly26. Furthermore, the handle assembly 12 may comprise a trigger assemblysuch as, for example, the trigger assembly 24. As described above, thetrigger assembly 24 may include a trigger 32 that operates inconjunction with a fixed handle 34.

In various instances, the trigger 32 can be operably coupled to areciprocating actuation member 402 (FIG. 21). In at least one example, alinkage assembly can be employed to couple the trigger 32 to thereciprocating actuation member 402. In certain instances, as illustratedin FIG. 21, the reciprocating actuation member 402 may be operablycoupled to the clamp member 64. In at least one example, a drive shaftsuch as, for example, the outer tubular sheath 56 of the elongated shaftassembly 14 may be employed to transmit actuation motions from thereciprocating actuation member 402 to the clamp member 64, for example.The reader will appreciate that, in certain instances, the inner tubularmember 158 of the elongated shaft assembly 114 can be employed as adrive shaft. In such instances, the inner tubular member 158 can beoperably coupled to the reciprocating actuation member 402, for example.

In any event, the trigger 32 can be pivotally movable relative to thefixed handle 34 to reciprocate the reciprocating actuation member 402between a first position, as illustrated in FIG. 21A, and a secondposition, as illustrated in FIG. 21B. In certain instances, the firstposition can be at a distal location to the second position, forexample. In certain instances, the clamp member 64 can be transitionedbetween an open configuration and a closed configuration with respect tothe ultrasonic blade 66 in response to the reciprocating motion of thereciprocating actuation member 402 between the first position and thesecond position, for example. In at least one example, the clamp member64 can be in a fully open configuration while the reciprocatingactuation member 402 is at the first position, as illustrated in FIG.21. In at least one example, if the path of the clamp member 64 towardthe ultrasonic blade 66 is not impeded, the clamp member 64 can be in afully closed configuration while the reciprocating actuation member 402is at the second position.

In certain instances, the trigger 32 can be pivotally movable in thedirection 33A toward the fixed handle 34 to transition the reciprocatingactuation member 402 toward the second position and transition the clampmember 64 toward the closed configuration. In certain instances, thetrigger 32 can be pivotally movable in the direction 33B away from thefixed handle 34 to transition the reciprocating actuation member 402toward the first position and transition the clamp member 64 toward theclosed configuration, for example.

In certain instances, a biasing mechanism 404 may cause the trigger 32to pivotally move in the direction 33B when the user releases thesqueezing force against the trigger 32. The biasing mechanism 404 maybias the reciprocating actuation member 402 toward the first positionand bias the clamp member 64 toward the open configuration, asillustrated in FIG. 21A. In certain instances, the biasing mechanism 404may comprise one or more springs. In at least one example, the biasingmechanism 404 may include a proximal spring 406, for example, and/or adistal spring 408, for example, as illustrated in FIG. 21.

In various instances, the biasing mechanism 404 may be configured toapply an initial load to the reciprocating actuation member 402 tomaintain the reciprocating actuation member 402 at the first position;in turn, the reciprocating actuation member 402 maintains the clampmember 64 in the open configuration, as illustrated in FIG. 21. Thereader will appreciate that the initial load applied by the biasingmechanism 404 against the reciprocating actuation member 402 defines, atleast in part, an initial force required to overcome the initial load tomotivate the reciprocating actuation member 402 from the first positiontoward the second position and motivate the clamp member 64 from theopen configuration toward the closed configuration, for example.

The reader will also appreciate that accurately and reproducibly settingand maintaining the initial load ensures uniformity of the initial forcerequired to overcome the initial load. Such uniformity aids a user ofthe surgical instrument 10 in developing a type of tactile memory whensqueezing the trigger 32 to generate the initial force. In other words,eliminating, or at least reducing, variability of the initial loadprovides a user of the surgical instrument 10 with an element ofpredictability in using the trigger 32 that facilitates developing atactile memory associated with squeezing the trigger 32, for example.Furthermore, accurately and reproducibly setting and maintaining theinitial load ensures that the surgical instrument 10 produces aconsistent and optimized clamp force on tissue, which creates consistentand optimum hemostasis and tissue effects.

In various instances, the handle assembly 12 may comprise a loadadjustment assembly 410, which can be employed to set and maintain theinitial load against the reciprocating actuation member 402 at apredetermined value. In certain instances, as illustrated in FIG. 21,the load adjustment assembly 410 can be coupled to a drive shaft of thesurgical instrument 10 such as, for example, the outer tubular sheath 56or inner tubular member 158. The load adjustment assembly 410 mayinclude a stop 412 and a load adjustment member 414. In certaininstances, the stop 412 can be disposed at a distal location relative tothe load adjustment member 414, for example. In at least one example,the stop 412 can be disposed at a proximal location to the loadadjustment member 414.

In certain instances, as illustrated in FIG. 21, the biasing mechanism404 can be disposed between the stop 412 and the load adjustment member414. The reciprocating actuation member 402 can be disposed between thestop 412 and the biasing mechanism 404. In certain instances, thereciprocating actuation member 402 is abutted against the stop 412 atthe first position, as illustrated in FIG. 21A. In certain instances, asdescribed above, the biasing mechanism 404 may include a proximal spring406 and a distal spring 408. A first washer 407 can be disposed betweenthe proximal spring 407 and the distal spring 408, for example. A secondwasher 409 can be disposed between the distal spring 408 and thereciprocating actuation member 402, for example. Other relativepositions and/or arrangements of the stop 412, the load adjustmentmember 414, and the biasing mechanism 404 with respect to each other arecontemplated by the present disclosure.

In various instances, the distance between the stop 412 and the loadadjustment member 414 can determine the initial load against thereciprocating actuation member 402. In certain instances, the loadadjustment member 414 is movable relative to the stop 412 to adjust theinitial load applied against the reciprocating actuation member 402 tothe predetermined value by adjusting the distance between the stop 412and the load adjustment member 414. In certain instances, upon reachingthe predetermined value of the initial load, the load adjustment member414 is fixed in position relative to the stop 412, as described below ingreater detail, to fix the distance between the stop 412 and the loadadjustment member 414.

In certain instances, movement of the load adjustment member 414relative to the stop 412 motivates the springs 406 and/or 408 of thebiasing mechanism 404 to change the load applied by the biasingmechanism 404 against the reciprocating actuation member 402. In atleast one example, movement of the load adjustment member 414 toward thestop 412 compresses the springs 406 and/or 408 of the biasing mechanism404 which increases the initial load applied by the biasing mechanism404 against the reciprocating actuation member 402. In at least oneexample, movement of the load adjustment member 414 away from the stop412 at least partially decompresses the springs 406 and/or 408 of thebiasing mechanism 404 which decreases the initial load applied by thebiasing mechanism 404 against the reciprocating actuation member 402.

In certain instances, the load adjustment assembly 410 may include acollar 416. The collar 416 can be attached to a drive shaft of thesurgical instrument 10 such as, for example, the outer tubular sheath 56or the inner tubular member 158. FIG. 23 shows the collar 416 assembledwith the outer tubular sheath 56. As illustrated in FIG. 23, the collar416 may comprise a cylindrical, or at least substantially cylindrical,shape which can be disposed around the outer tubular sheath 56, forexample. In certain instances, as illustrated in FIG. 23, the collar 416may comprise a plurality of mating members 416A configured form matingengagement with a plurality of corresponding openings 56A of the outertubular sheath 56, for example. As illustrated in FIG. 23, the mattingmembers 416A may be disposed on an inner wall of the collar 416. In atleast one example, the collar 416 can be glued to the outer tubularsheath 56. In another example, the collar 416 can be welded onto theouter tubular sheath 56. Other techniques for attaching the collar 416to the outer tubular sheath 56 are contemplated by the presentdisclosure.

As illustrated in FIG. 23, the collar 416 can be attached to a proximalportion of the outer tubular sheath 56. In certain instances, the collar416 and the stop 412 can be manufactured as a single unit. The stop 412may be comprised of a flange positioned at a distal end of the collar416, for example. In certain instances, the load adjustment member 414can be coupled to the collar 416. For example, the collar 416 mayinclude a threaded proximal portion 416 b which can be configured toreceive the load adjustment member 414. The load adjustment member 414can, for example, be threadedly engaged with the threaded proximalportion 416 b, as illustrated in FIG. 23. In such instances, rotation ofthe load adjustment member 414 relative to the collar 416 in a firstdirection, for example a clockwise direction, may advance the loadadjustment member 414 toward the stop 412, and rotation of the loadadjustment member 414 relative to the collar 416 in a second direction,for example a counterclockwise direction, may retract the loadadjustment member 414 away from the stop 412. Advancement of the loadadjustment member 414 toward the stop 412 may compress the springs 406and/or 408 thereby increasing the load applied against the reciprocatingactuation member 402. On the other hand, retraction of the loadadjustment member 414 away from the stop 412 may allow the springs 406and/or 408 to at least partially decompress thereby reducing the loadapplied against the reciprocating actuation member 402.

In certain instances, to set the initial load applied against thereciprocating actuation member 402 to a predetermined value, a loadmonitoring unit can be employed. The load exerted by the biasingmechanism 404 against the reciprocating actuation member 402 can bemonitored by the load monitoring unit. Meanwhile, the load adjustmentmember 414 can be turned clockwise and/or counterclockwise, for example,to adjust the initial load to the predetermined value based on feedbackfrom the load monitoring unit. Once the initial load is set to thepredetermined value, in certain instances, a final position of the loadadjustment member 414 can be fixed to maintain the initial load at thepredetermined value. In certain instances, the final position of theload adjustment member 414 can be fixed by fixing the load adjustmentmember 414 to the collar 416. In at least one example, the finalposition of the load adjustment member 414 can be fixed by welding theload adjustment member 414 to the collar 416 at the final position. Inat least one example, the final position of the load adjustment member414 can be fixed by gluing the load adjustment member 414 to the collar416 at the final position. Other techniques for fixing the loadadjustment member 414 to the collar 416 at the final position arecontemplated by the present disclosure.

Referring primarily to FIG. 24, in certain instances, the handleassembly 12 of the surgical instrument 10 may include a load adjustmentassembly 510, which is similar in many respects to the load adjustmentassembly 410. For example, the load adjustment assembly 510 includes thebiasing mechanism 404. Also, like the load adjustment assembly 410, theload adjustment assembly 510 is operably coupled to a drive shaft of thesurgical instrument 10 such as, for example, the outer tubular sheath 56(FIG. 24) or the inner tubular member 158. Furthermore, like the loadadjustment assembly 410, the load adjustment assembly 510 can beemployed to adjust an initial load applied against a clamp member of thesurgical instrument 10.

Referring to FIG. 24, the load adjustment assembly 510 may include aload adjustment member 514. The load adjustment member 514 may becomprised of a stop 512, a body portion 516, and a plurality ofprojections 516A extending proximally from the body portion 516. Incertain instances, the stop 512 may be comprised of a flange memberdisposed at distal end of the body portion 516, as illustrated in FIG.24. In certain instances, each of the plurality of projections 516A maybe comprised of a tab extending proximally from the body portion 516, asillustrated in FIG. 25.

In certain instances, as illustrated in FIGS. 24 and 25, the bodyportion 516 of the load adjustment assembly 510 may comprise acylindrical, or at least substantially cylindrical, shape which can bedisposed around the drive shaft of the surgical instrument 10. Forexample, FIG. 24 shows the body portion 516 disposed around the outertubular sheath 56.

Further to the above, as illustrated in FIG. 24, the load adjustmentassembly 510 may also include a receiving end portion 530, which can becomprised of a flange member disposed at a proximal end of a drive shaftof the surgical instrument 10 such as, for example, the outer tubularsheath 56 or the inner tubular member 158. In certain instances, thereceiving end portion 530 may comprise a plurality of slots 530A (FIG.25), which can be configured to receive the projections 516A. In certaininstances, the receiving end portion 530 can be integrated with thedrive shaft of the surgical instrument 10. In certain instances, thereceiving end portion 530 and the drive shaft of the surgical instrument10 can be manufactured together as a single unit. In other instances,the receiving end portion 530 and the drive shaft of the surgicalinstrument 10 can be manufactured separately and attached to each otherduring assembly of the surgical instrument 10, for example.

In certain instances, as illustrated in FIG. 24, the biasing mechanism404 can be disposed between the stop 512 and the receiving end portion530. The reciprocating actuation member 402 can be disposed between thestop 512 and the biasing mechanism 404. Other relative positions and/orarrangements of the stop 512, the receiving end portion 530, and thebiasing mechanism 404 with respect to each other are contemplated by thepresent disclosure.

As described above, in certain instances, the clamp member 64 can betransitioned between an open configuration and a closed configurationwith respect to the ultrasonic blade 66 in response to the reciprocatingmotion of the reciprocating actuation member 402 between a firstposition and a second position, for example. In certain instances, thereciprocating actuation member 402 is abutted against the stop 512 atthe first position.

In various instances, the distance between the stop 512 and thereceiving end portion 530 of the load adjustment assembly 510 candetermine the initial load against the reciprocating actuation member402 at the first position. In certain instances, the load adjustmentmember 514 is slidably movable relative to the outer tubular sheath 56to adjust the initial load applied against the reciprocating actuationmember 402 to a predetermined value by adjusting the distance betweenthe stop 512 and the receiving end portion 530. In certain instances,upon reaching the predetermined value of the initial load, theprojections 516A are fixed to the receiving end portion 530 to fix thedistance between the stop 512 and the receiving end portion 530.

In certain instances, movement of the load adjustment member 514relative to the receiving end portion 530 motivates the springs 406and/or 408 of the biasing mechanism 404 to change the load applied bythe biasing mechanism 404 against the reciprocating actuation member402. In at least one example, movement of the load adjustment member 514toward the receiving end portion 530 compresses the springs 406 and/or408 of the biasing mechanism 404 which increases the initial loadapplied by the biasing mechanism 404 against the reciprocating actuationmember 402. In at least one example, movement of the load adjustmentmember 514 away from the receiving end portion 530 at least partiallydecompresses the springs 406 and/or 408 of the biasing mechanism 404which decreases the initial load applied by the biasing mechanism 404against the reciprocating actuation member 402.

In certain instances, to set the initial load to a predetermined value,a load monitoring unit can be employed. The load exerted by the biasingmechanism 404 against the reciprocating actuation member 402 can bemonitored by the load monitoring unit. Meanwhile, the load adjustmentmember 514 can be slidably moved relative to the receiving end portion530 to adjust the distance between stop 512 and the receiving endportion 530 based on feedback from the load monitoring unit until thepredetermined value of the initial load is realized. As the loadadjustment member 514 is moved relative to the outer tubular sheath 56,the projections 516A slide with respect to the slots 530A.

Once the initial load is set to the predetermined value, in certaininstances, a final position of the load adjustment member 514 can befixed to maintain the initial load at the predetermined value. Incertain instances, the final position of the load adjustment member 514can be fixed by fixing the projections 516A to the receiving end portion530. In at least one example, the final position of the load adjustmentmember 514 can be fixed by bending or crimping the distal ends of theprojection 516A that extend proximally beyond their corresponding slots530A, as illustrated in FIG. 24. In certain instances, the distal endsof the projections 516A that extend proximally beyond theircorresponding slots 530A can be welded to the receiving end portion 530at the final position of the load adjustment member 514, for example. Inat least one example, the distal ends of the projection 516A that extendproximally beyond their corresponding slots 530A can be glued to thereceiving end portion 530 at the final position of the load adjustmentmember 514, for example. Other techniques for fixing the load adjustmentmember 514 to the receiving end portion 530 at the final position arecontemplated by the present disclosure.

Referring primarily to FIGS. 26 and 26A, in certain instances, thehandle assembly 12 of the surgical instrument 10 may include a loadadjustment assembly 610, which is similar in many respects to the loadadjustment assemblies 410 and/or 510. For example, the load adjustmentassembly 610 includes the biasing mechanism 404. Also, like the loadadjustment assemblies 410 and 510, the load adjustment assembly 610 isoperably coupled to a drive shaft of the surgical instrument 10 such as,for example, the outer tubular sheath 56 or the inner tubular member158. Furthermore, like the load adjustment assemblies 410 and 510, theload adjustment assembly 610 can be employed to adjust an initial loadapplied against a clamp member of the surgical instrument 10.

Referring to FIGS. 26 and 26A, the load adjustment assembly 610 mayinclude a stop 612 and a load adjustment member 614. In certaininstances, the stop 612 may be comprised of a flange member disposedaround, or at least partially around, a proximal portion of a driveshaft of the surgical instrument 10 such as, for example, the outertubular sheath 56 and the inner tubular member 158. For example, FIG. 26shows the stop 612 disposed around a proximal portion of the outertubular sheath 56.

In certain instances, as illustrated in FIG. 26A, the load adjustmentmember 614 may be assembled with the outer tubular sheath 56 such thatthe biasing mechanism 404 is disposed between the stop 612 and the loadadjustment member 614. In certain instances, the load adjustment member614 may comprise a cylindrical, or at least substantially cylindrical,shape which can be slidably inserted around a proximal end of the driveshaft of the surgical instrument 10. For example, FIG. 26A shows theload adjustment member 614 disposed around the proximal portion of theouter tubular sheath 56. In certain instances, the stop 612 can bedisposed at a distal location relative to the load adjustment member614, for example. Alternatively, the stop 612 can be disposed at aproximal location relative to the load adjustment member 614. Thereciprocating actuation member 402 can be disposed between the stop 612and the biasing mechanism 404. In certain instances, the reciprocatingactuation member 402 is abutted against the stop 612 at the firstposition, as illustrated in FIG. 26A. Other relative positions and/orarrangements of the stop 612, the load adjustment member 614, and thebiasing mechanism 404 with respect to each other are contemplated by thepresent disclosure.

In various instances, the relative distance between the stop 612 and theload adjustment member 614 can determine the initial load against thereciprocating actuation member 402. In certain instances, the loadadjustment member 614 is slidably movable relative to the stop 612 toadjust the initial load applied against the reciprocating actuationmember 402 to the predetermined value by adjusting the distance betweenthe stop 612 and the load adjustment member 614. In certain instances,upon reaching the predetermined value of the initial load, the loadadjustment member 614 is fixed in position relative to the stop 612, asdescribed below in greater detail, by fixing the distance between thestop 612 and the load adjustment member 614.

In certain instances, movement of the load adjustment member 614relative to the stop 612 motivates the springs 406 and/or 408 of thebiasing mechanism 404 to change the load applied by the biasingmechanism 404 against the reciprocating actuation member 402. In atleast one example, movement of the load adjustment member 416 toward thestop 612 compresses the springs 406 and/or 408 of the biasing mechanism404, which increases the initial load applied by the biasing mechanism404 against the reciprocating actuation member 402. In at least oneexample, movement of the load adjustment member 614 away from the stop612 at least partially decompresses the springs 406 and/or 408 of thebiasing mechanism 404, which decreases the initial load applied by thebiasing mechanism 404 against the reciprocating actuation member 402.

In certain instances, to set the initial load to a predetermined value,a load monitoring unit can be employed. The load exerted by the biasingmechanism 404 against the reciprocating actuation member 402 can bemonitored by the load monitoring unit. Meanwhile, the load adjustmentmember 614 can be slidably moved relative to the stop 612 to adjust thedistance between the load adjustment member 614 and the stop 612 untilthe predetermined value of the initial load is realized. Once theinitial load is set to the predetermined value, in certain instances, afinal position of the load adjustment member 614 can be fixed tomaintain the initial load at the predetermined value by fixing thedistance between the load adjustment member 614 and the stop 612. Incertain instances, the final position of the load adjustment member 614can be fixed by fixing the load adjustment member 614 to the outertubular sheath 56. In at least one example, the final position of theload adjustment member 614 can be fixed by welding the load adjustmentmember 614 to the outer tubular sheath 56 at the final position. In atleast one example, the final position of the load adjustment member 614can be fixed by gluing the load adjustment member 614 to the outertubular sheath 56 at the final position. Other techniques for fixing theload adjustment member 614 to the outer tubular sheath 56 at the finalposition are contemplated by the present disclosure.

Referring primarily to FIG. 27, in certain instances, the handleassembly 12 of the surgical instrument 10 may include a load adjustmentassembly 710, which is similar in many respects to the load adjustmentassemblies 410, 510, and/or 610. For example, like the load adjustmentassemblies 410, 510, and 610, the load adjustment assembly 710 isoperably coupled to a drive shaft of the surgical instrument 10 such as,for example, the outer tubular sheath 56 or the inner tubular member158. Furthermore, the load adjustment assembly 710 can be employed toadjust an initial load (a pre-load) applied against a biasing member704. As described in greater detail below, the biasing member 704 can beconfigured to protect from transmission of excessive actuation forcesgreater than the pre-load to a clamp member of the surgical instrument10.

Referring to FIG. 27, the load adjustment assembly 710 may include adistal yoke portion 712, a proximal yoke portion 716, and a loadadjustment member 714 extending between the distal yoke portion 712 andthe proximal yoke portion 716. In certain instances, the biasing member704 may comprise a tension spring which can be located at leastpartially around the load adjustment member 714, as illustrated in FIG.27. In certain instances, a distal end of the biasing member 704 can beconnected to the distal yoke portion 712 and a proximal end of thebiasing member 704 can be connected to the proximal yoke portion 716.

Further to the above, the distal yoke portion 712 can be operablycoupled to a drive shaft of the surgical instrument 10 such as, forexample, the outer tubular sheath 56 or the inner tubular member 158.FIG. 27 shows a drive collar 711 coupling the distal yoke portion 712 tothe inner tubular member 158. In addition, the proximal yoke portion 716may be operably coupled to the trigger 32 of the handle assembly 12. Forexample, a linkage assembly 732 may couple the trigger 32 to theproximal yoke portion 716, as illustrated in FIG. 27.

In certain instances, the trigger 32 can be pivotably moved relative tothe fixed handle 34 to reciprocate the inner tubular member 158 axiallybetween a first position and a second position. As described above, theinner tubular member 158 can be pivotably coupled to a clamp member suchas, for example, the clamp member 164. In certain instances, the firstposition can be at a distal location to the second position, forexample. In certain instances, the clamp member 164 can be transitionedbetween an open configuration and a closed configuration with respectthe ultrasonic blade 66 in response to the reciprocating motion of theinner tubular member 158 between the first position and the secondposition, for example. In at least one example, the clamp member 164 canbe in a fully open configuration while the inner tubular member 158 isat the first position. In at least one example, if the path of the clampmember 164 toward the ultrasonic blade 66 is not impeded, the clampmember 164 can be in a fully closed configuration while the innertubular member 158 is at the second position.

In use, the trigger 32 can be pivoted toward the fixed handle 34 toapply a force to the load adjustment assembly 710 to transition the loadadjustment assembly 710 and the inner tubular member 158 proximallythereby causing the clamp member 164 to be actuated toward the closedconfiguration, for example. In certain instances, the force applied tothe clamp member 164 of the surgical instrument 10 by pivotal movementof the trigger 32 acting through the load adjustment assembly 710 can belimited, or at least partially limited, by the biasing member 704. Incertain instances, the biasing member 704 can be a tension coil springwhich can be stretched between the proximal yoke portion 716 and thedistal yoke portion 712 to set a biasing member pre-load to apredetermined value. The pre-load can be adjusted to the predeterminedvalue by employing the load adjustment member 714 to adjust the distancebetween the proximal yoke portion 716 and the distal yoke member 712, asdescribed in greater detail below.

In certain instances, the biasing member 704 may limit forcetransmission from the trigger 32 to the clamp member 164 if excessiveforce is applied to the trigger 32 by a user of the surgical instrument10. When the force, which is applied by the user to the trigger 32, isless than the pre-load limit of the biasing member 704, the loadadjustment assembly 710 moves as a single unit to reciprocate the innertubular member 158 and actuate the clamp member 164. In other words, aforce less than the pre-load limit of the biasing member 704 does notresult in relative motion between the proximal yoke portion 716 and thedistal yoke portion 712.

However, when the force, which is applied by the user to the trigger 32,exceeds the pre-load limit of the biasing member 704, the biasing member704 may be further stretched between the proximal yoke portion 716 andthe distal yoke portion 712 thereby causing the proximal yoke portion716 to move independently from the distal yoke portion 712 for a limiteddegree thereby limiting the transmission of the excessive force to theinner tubular member 158 and the clamp member 164.

In certain instances, as illustrated in FIG. 28, the load adjustmentmember 714 may comprise a threaded proximal portion 714A and a distalstop 714B. The distal stop 714B can be abutted against the distal yokeportion 712. The threaded proximal portion 714A can be received, or atleast partially received, within a receiving portion 716A of theproximal yoke portion 716. For example, the receiving portion 716A mayinclude a thread on an internal wall of the receiving portion 716A whichcan be threadedly engaged with the threaded proximal portion 714A, forexample.

The load adjustment member 714 can be employed to stretch the tensionspring of the biasing member 704 between the proximal yoke portion 716and the distal yoke portion 712 to an initial stretched conditioncorresponding to a desired pre-load by adjusting the distance betweenthe proximal yoke portion 716 and the distal yoke portion 712. Forexample, rotation of the load adjustment member 714 relative to theproximal yoke portion 716 in a first direction, for example a clockwisedirection, may cause the proximal yoke portion 716 to move toward thedistal yoke portion 712 thereby decreasing the distance between theproximal yoke portion 716 and the distal yoke portion 712.Alternatively, rotation of the load adjustment member 714 relative tothe proximal yoke portion 716 in a second direction opposite the firstdirection, for example a counterclockwise direction, may cause theproximal yoke portion 716 to move away from the distal yoke portion 712thereby increasing the distance between the proximal yoke portion 716and the distal yoke portion 712. Because the biasing member is stretchedbetween the proximal yoke portion 716 and the distal yoke portion 712,increasing the distance between the proximal yoke portion 716 and thedistal yoke portion 712 may increase the pre-load applied to the biasingmember 704. On the other hand, decreasing the distance between theproximal yoke portion 716 and the distal yoke portion 712 may decreasethe pre-load applied to the biasing member 704.

In certain instances, the pre-load applied against the biasing member704 is set to a predetermined value during the assembly of the surgicalinstrument 10. To set the pre-load, the load adjustment member 714 canbe turned clockwise and/or counterclockwise, for example, until thepredetermined value of the pre-load load is realized by a loadmonitoring unit, for example. Once the pre-load is set to thepredetermined value, the load adjustment assembly 710 can be assembledwith the handle assembly 12.

In certain instances, the distance between the proximal yoke portion 716and the distal yoke portion 712 can be fixed to maintain the pre-load atthe predetermined value. In certain instances, the distance between theproximal yoke portion 716 and the distal yoke portion 712 can be fixedby fixing the load adjustment member 714 to proximal yoke portion 716.In at least one example, the load adjustment member 714 can be fixed tothe proximal yoke portion 716 by welding the load adjustment member 714to the proximal yoke portion 716. In at least one example, the loadadjustment member 714 can be fixed to the proximal yoke portion 716 bygluing the load adjustment member 714 to the proximal yoke portion 716.Other techniques for fixing the load adjustment member 714 to theproximal yoke portion 716 are contemplated by the present disclosure.

Referring now to FIG. 29, in certain instances, the handle assembly 12of the surgical instrument 10 may include a load adjustment assembly810, which is similar in many respects to the load adjustment assembly710. For example, like the load adjustment assembly 710, the loadadjustment assembly 810 is operably coupled to a drive shaft of thesurgical instrument 10 such as, for example, the outer tubular sheath 56or the inner tubular member 158. Furthermore, like the load adjustmentassembly 710, the load adjustment assembly 810 can be employed to adjustan initial load (a pre-load) applied against a biasing member 804. Asdescribed in greater detail below, the biasing member 804 can beconfigured to protect from transmission of excessive actuation forcesgreater than the pre-load to a clamp member of the surgical instrument10.

As illustrated in FIG. 29, the load adjustment assembly 810 may includea distal yoke portion 812, a proximal yoke portion 816, and a loadadjustment member 814. In certain instances, the load adjustment member814 may comprise a threaded proximal portion 814 a and a distal stop 814b. In certain instances, the biasing member 804 may comprise acompression spring which can be located at least partially around a bodyportion 814 c of the load adjustment member 814. In such instances, thebiasing member 804 can be compressed between the distal stop 814 b and acoupling member 812 a of the distal yoke portion 812.

In certain instances, as illustrated in FIG. 29, the coupling member 812a can be movably engaged with the load adjustment member 814. Forexample, the coupling member 812 a may comprise a through-hole which canbe configured to receive the body portion 814 c of the load adjustmentmember 814. In certain instances, the coupling member 812 a can beslidably moved relative to the body portion 814 c of the load adjustmentmember 814, for example. In such instances, the biasing member 804 maycause the coupling member 812 a of the distal yoke portion 812 to beabutted against the proximal yoke portion 816, as illustrated in FIG.29.

Further to the above, referring again to FIG. 29, the threaded proximalportion 814 a can be received, or at least partially received, within areceiving portion 816 a of the proximal yoke portion 816. For example,the receiving portion 816 a may include a thread on an internal wall ofthe receiving portion 816 a which can be threadedly engaged with thethreaded proximal portion 814 a, for example.

Further to the above, the distal yoke portion 812 can be operablycoupled to a drive shaft of the surgical instrument 10 such as, forexample, the outer tubular sheath 56 or the inner tubular member 158.FIG. 29 shows a drive collar 811 coupling the distal yoke portion 812 tothe inner tubular member 158. In addition, the proximal yoke portion 816may be operably coupled to the trigger 32 of the handle assembly 12. Forexample, a linkage assembly may couple the trigger 32 to the proximalyoke portion 816. As described above, the trigger 32 can be pivotablymoved relative to the fixed handle 34 to reciprocate the inner tubularmember 158 axially between a first position and a second position; andthe clamp member 164 can be transitioned between an open configurationand a closed configuration with respect the ultrasonic blade 66 inresponse to the reciprocating motion of the inner tubular member 158between the first position and the second position.

In use, the trigger 32 can be pivoted toward the fixed handle 34 toapply a force to the load adjustment assembly 810 to transition the loadadjustment assembly 810 and the inner tubular member 158 proximallythereby causing the clamp member 164 to be actuated toward the closedconfiguration, for example. The force applied to the clamp member 164 ofthe surgical instrument 10 by pivotal movement of the trigger 32 actingthrough the load adjustment assembly 810 can be limited, or at leastpartially limited, by the biasing member 804. In certain instances, asdescribed above, the biasing member 804 may comprise a compressionspring which can be compressed between the distal stop 814 b and thecoupling member 812 a, abutted against the proximal yoke portion 816, toset a biasing member pre-load to a predetermined value. The pre-load canbe adjusted to the predetermined value by employing the load adjustmentmember 714 to adjust the distance between the distal stop 814 b and thecoupling member 812 a of the distal yoke portion 812, as described ingreater detail below.

In certain instances, the biasing member 804 may limit forcetransmission from the trigger 32 to the clamp member 164 if excessiveforce is applied to the trigger 32 by a user of the surgical instrument10. When the force, which is applied by the user to the trigger 32, isless than the pre-load limit of the biasing member 704, the loadadjustment assembly 810 moves as a single unit to reciprocate the innertubular member 158 and actuate the clamp member 164. In other words, aforce less than the pre-load limit of the biasing member 804 does notresult in relative motion between the distal stop 814 b and the couplingmember 812 a. Said another way, if the force applied by the user throughthe trigger 32 is less than the pre-load limit of the biasing member804, the coupling member 812 a remains abutted against the proximal yokeportion 816 as the load adjustment assembly 810 moves to cause the innertubular member 158 to actuate the clamp member 164 to the closedconfiguration.

However, when the force, which is applied by the user to the trigger 32,exceeds the pre-load limit of the biasing member 804, the biasing member804 may be further compressed between the distal stop 814 b and thecoupling member 812 a thereby causing the coupling member 812 a to moveaway from the proximal yoke portion 816 for a limited degree therebylimiting the transmission of the excessive force to the inner tubularmember 158 and the clamp member 164.

The load adjustment member 814 can be employed to compress the biasingmember 804 between the distal stop 814 b and the coupling member 812 ato an initial compressed condition corresponding to a desired pre-loadby adjusting the distance between the distal stop 814 b and the proximalyoke portion 816 abutting against the coupling member 812 a. Forexample, rotation of the load adjustment member 814 relative to theproximal yoke portion 816 in a first direction, for example a clockwisedirection, may cause the proximal yoke portion 816 to move toward thedistal yoke portion 812 thereby decreasing the distance between thedistal stop 814 b and the coupling member 812 a. Alternatively, rotationof the load adjustment member 814 relative to the proximal yoke portion816 in a second direction opposite the first direction, for example acounterclockwise direction, may cause the proximal yoke portion 816 tomove away from the distal yoke portion 812 thereby increasing thedistance between the distal stop 814 b and the coupling member 812 a.Because the biasing member is compressed between the distal stop 814 band the coupling member 812 a, increasing the distance between thedistal stop 814 b and the coupling member 812 a may decrease thepre-load applied to the biasing member 804. On the other hand,decreasing the distance between the distal stop 814 b and the couplingmember 812 a may increase the pre-load applied to the biasing member804.

In certain instances, the pre-load applied against the biasing member804 is set to a predetermined value during the assembly of the surgicalinstrument 10. To set the pre-load, the load adjustment member 814 canbe turned clockwise and/or counterclockwise, for example, until thepredetermined value of the pre-load is realized by a load monitoringunit, for example. Once the pre-load is set to the predetermined value,the load adjustment assembly 810 can be assembled with the handleassembly 12.

In certain instances, the distance between the distal stop 814 b and thecoupling member 812 a can be fixed to maintain the pre-load at thepredetermined value. In certain instances, the distance between thedistal stop 814 b and the coupling member 812 a can be fixed by fixingthe load adjustment member 814 to proximal yoke portion 816. In at leastone example, the load adjustment member 814 can be fixed to the proximalyoke portion 816 by welding the load adjustment member 814 to theproximal yoke portion 816. In at least one example, the load adjustmentmember 814 can be fixed to the proximal yoke portion 816 by gluing theload adjustment member 814 to the proximal yoke portion 816. Othertechniques for fixing the load adjustment member 814 to the proximalyoke portion 816 are contemplated by the present disclosure.

Although the various embodiments of the devices have been describedherein in connection with certain disclosed embodiments, manymodifications and variations to those embodiments may be implemented.Also, where materials are disclosed for certain components, othermaterials may be used. Furthermore, according to various embodiments, asingle component may be replaced by multiple components, and multiplecomponents may be replaced by a single component, to perform a givenfunction or functions. The foregoing description and following claimsare intended to cover all such modification and variations.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. An ultrasonic surgical instrument, comprising: ashaft assembly, comprising: an inner tube defining a longitudinal axis;and an outer tube at least partially surrounding the inner tube, theouter tube movable relative to the inner tube along the longitudinalaxis between a first position and a second position; an ultrasonictransducer assembly comprising an ultrasonic transducer; and an endeffector assembly, comprising: an ultrasonic blade acoustically coupledto the ultrasonic transducer, wherein the ultrasonic blade extendsthrough the inner tube, and wherein the ultrasonic blade extends atleast partially along the longitudinal axis; and a clamp memberpivotably movable relative to the ultrasonic blade between an openconfiguration and an approximated configuration with respect to theultrasonic blade, wherein the clamp member is pivotably coupled to theinner tube, wherein the clamp member is pivotably coupled to the outertube, and wherein movement of the outer tube relative to the inner tubebetween the first position and the second position transitions the clampmember between the open configuration and the approximate configuration.2. The ultrasonic surgical instrument of claim 1, wherein the ultrasonicblade is coupled to the inner tube.
 3. The ultrasonic surgicalinstrument of claim 1, wherein the inner tube comprises a distalconnection member, and wherein the clamp member is pivotably coupled tothe distal connection member.
 4. The ultrasonic surgical instrument ofclaim 3, wherein the distal connection member comprises a proximalmating element, and wherein the inner tube comprises a correspondingmating element for mating engagement with the proximal mating element ofthe distal connection member.
 5. The ultrasonic surgical instrument ofclaim 4, wherein the proximal mating element of distal connection memberis fixedly attached to the corresponding mating element of the innertube.
 6. The ultrasonic surgical instrument of claim 5, wherein theouter tube comprises a partially open distal portion, and wherein theclamp member is pivotably coupled to the partially open distal portion.7. The ultrasonic surgical instrument of claim 6, wherein the ultrasonicblade extends between the distal connection member and the partiallyopen distal portion.
 8. The ultrasonic surgical instrument of claim 1,wherein the outer tube is advanced distally relative to the inner tubeto transition the clamp member from the approximated configuration tothe open configuration.
 9. The ultrasonic surgical instrument of claim1, wherein the outer tube is retracted proximally relative to the innertube to transition the clamp member from the open configuration to theapproximated configuration.
 10. The ultrasonic surgical instrument ofclaim 1, further comprising a sealing member disposed between the innertube and the ultrasonic blade.
 11. An ultrasonic surgical instrument,comprising: a shaft assembly, comprising: an inner tube defining alongitudinal axis, the inner tube comprising a first alignment feature;and an outer tube extending along the longitudinal axis, wherein theouter tube at least partially surrounds the inner tube; an ultrasonictransducer assembly comprising an ultrasonic transducer; and an endeffector assembly, comprising: an ultrasonic blade comprising a secondalignment feature, wherein the ultrasonic blade is acoustically coupledto the ultrasonic transducer, wherein the ultrasonic blade extendsthrough the inner tube, and wherein the first alignment feature isaligned with the second alignment feature; and a clamp member pivotablymovable between an open configuration and an approximated configurationrelative to the ultrasonic blade, wherein the clamp member is pivotablycoupled to the outer tube, and wherein relative movement between theouter tube and the inner tube transitions the clamp member between theopen configuration and the approximated configuration.
 12. Theultrasonic surgical instrument of claim 11, wherein the second alignmentfeature is positioned at a distal node of the ultrasonic blade.
 13. Theultrasonic surgical instrument of claim 11, wherein the inner tubecomprises a distal connection member, wherein the clamp member ispivotably coupled to the distal connection member, and wherein the firstalignment feature is disposed on an inner wall of the distal connectionmember.
 14. The ultrasonic surgical instrument of claim 11, wherein theultrasonic blade comprises a sealing member disposed at least partiallyaround the ultrasonic blade, and wherein the sealing member comprisesthe second alignment feature.
 15. The ultrasonic surgical instrument ofclaim 11, wherein the first alignment feature comprises a first flatsection, wherein the second alignment feature comprises a second flatsection corresponding to the first flat section.
 16. The ultrasonicsurgical instrument of claim 15, wherein the clamp member is actuatableto generate a clamping force, and wherein the clamping force issubstantially perpendicular to a plane defined by the second flatsection.
 17. The ultrasonic surgical instrument of claim 11, wherein thesecond alignment feature comprises a slot, and wherein the firstalignment feature comprises a constraining member configured to bereceived in the slot.
 18. The ultrasonic surgical instrument of claim17, wherein the inner tube comprises a wall including a side opening,and wherein the constraining member is received by the slot through theside opening.
 19. The ultrasonic surgical instrument of claim 18,wherein the constraining member is fixedly attached to the wall at theside opening.
 20. The ultrasonic surgical instrument of claim 11,wherein the second alignment feature defines a plane, and wherein thefirst alignment feature and the clamp member are on opposite sides ofthe plane.
 21. The ultrasonic surgical instrument of claim 11, whereinthe clamp member is actuatable to generate a clamping force, and whereinthe clamping force biases the second alignment feature toward the firstalignment feature.
 22. The ultrasonic surgical instrument of claim 11,wherein the inner tube comprises an insert, wherein the first alignmentfeature is disposed on a wall of the insert, wherein the ultrasonicblade partially extends along the wall.
 23. The ultrasonic surgicalinstrument of claim 11, wherein the first alignment feature comprises afirst flat section, wherein the second alignment feature comprises asecond flat section corresponding to the first flat section.
 24. Anultrasonic surgical instrument, comprising: an ultrasonic transducerassembly comprising an ultrasonic transducer; a support shaft comprisinga first alignment feature; an ultrasonic blade comprising a secondalignment feature, wherein the ultrasonic blade is acoustically coupledto the ultrasonic transducer; and a clamp member pivotably movable abouta pivot between an open configuration and an approximated relative tothe ultrasonic blade, wherein the clamp member is actuatable to generatea clamping force against tissue captured between the clamp member andthe ultrasonic blade, and wherein the clamping force biases the secondalignment feature toward the first alignment feature.
 25. The ultrasonicsurgical instrument of claim 24, wherein the first alignment feature andthe clamping arm are on opposite sides of the second alignment feature.26. An ultrasonic surgical instrument for use in a surgical procedure,comprising: a drive shaft, comprising: a distal end portion; and aproximal end portion; an ultrasonic transducer assembly comprising anultrasonic transducer; an ultrasonic blade, wherein the ultrasonic bladeis acoustically coupled to the ultrasonic transducer; an reciprocatingactuation member operably coupled to the proximal end portion of thedrive shaft, wherein the reciprocating actuation member is actuatablebetween a first position and a second position; a clamp member pivotablycoupled to the distal end portion of the drive shaft, wherein the clampmember is pivotably movable between an open configuration and anapproximated configuration relative to the ultrasonic blade in responseto movement of the reciprocating actuation member between the firstposition and the second position; and a load adjustment assembly forsetting an initial load applied against the reciprocating actuationmember, wherein the initial load is maintained by the load adjustmentassembly at the predetermined value during the surgical procedure. 27.The ultrasonic surgical instrument of claim 26, wherein the loadadjustment assembly comprises: a stop coupled to the drive shaft at theproximal end portion; a load adjustment member attachable to the driveshaft at a proximal location to the stop; and a biasing member extendingbetween the stop and the load adjustment member, wherein the biasingmember is configured to apply the initial load against the reciprocatingactuation member, wherein the initial load is adjustable to thepredetermined value by adjusting a distance between the stop and theload adjustment member.
 28. The ultrasonic surgical instrument of claim27, wherein the load adjustment member is fixedly attached to the driveshaft at a final distance between the stop and the load adjustmentmember, wherein the final distance corresponds to the predeterminedvalue of the initial load.
 29. The ultrasonic surgical instrument ofclaim 26, wherein the load adjustment assembly comprises: a collar atleast partially disposed around the proximal end portion of the driveshaft, wherein the collar comprises a stop at a distal end thereof; aload adjustment member at proximal location to the stop; and a biasingmember extending between the stop and the load adjustment member,wherein the biasing member is configured to apply the initial loadagainst the reciprocating actuation member, wherein the initial load isadjustable to the predetermined value by adjusting a distance betweenthe stop and the load adjustment member.
 30. The ultrasonic surgicalinstrument of claim 29, wherein the collar comprises a threaded proximalportion, wherein the load adjustment member is threadedly engaged withthe threaded proximal portion.
 31. The ultrasonic surgical instrument ofclaim 26, wherein the load adjustment assembly comprises: a loadadjustment member slidably movable relative to the drive shaft, whereinthe load adjustment member comprises: a body portion; a stop extendingdistally from the body portion; and at least one projection extendingproximally from the body portion; and a yoke comprising a receiving endportion, wherein the receiving end portion includes at least one slotconfigured to receive the at least one projection.
 32. The ultrasonicsurgical instrument of claim 31, further comprising a biasing membercompressed between the stop and the reciprocating actuation member,wherein the biasing member is configured to abut the reciprocatingactuation member against the yoke by applying the initial load againstthe reciprocating actuation member, and wherein the initial load isadjustable to the predetermined value by adjusting a distance betweenthe stop and the yoke.
 33. The ultrasonic surgical instrument of claim32, wherein the at least one projection is fixed to the receiving endportion at a final distance between the stop and the yoke, and whereinthe final distance corresponds to the predetermined value of the initialload.